Versacem Acetabular Shell and Double Mobility HC Liners

GUDID 07630542703928

Double Mobility HC Liner Ø28/DMC

Medacta International SA

Acetabular shell
Primary Device ID07630542703928
NIH Device Record Key4d3b02fd-422b-4475-81be-648884b2f0de
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersacem Acetabular Shell and Double Mobility HC Liners
Version Model Number01.26.2846MHC
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630542703928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

On-Brand Devices [Versacem Acetabular Shell and Double Mobility HC Liners]

07630971265738Versacem Metalback Ø42 mm
07630971265721Versacem Metalback Ø40 mm
07630971265707Double Mobility HC Liner Ø22.2/DMAZ
07630542703928Double Mobility HC Liner Ø28/DMC
07630030808449Versacem Metalback Ø56 mm
07630030808432Versacem Metalback Ø54 mm
07630030808425Versacem Metalback Ø52 mm
07630030808418Versacem Metalback Ø50 mm
07630030808401Versacem Metalback Ø48 mm
07630030808395Versacem Metalback Ø46 mm
07630030808388Versacem Metalback Ø44 mm

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